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The Reliance Lumbar IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. Additional supplemental fixation is not necessary for the Lumbar IBF-S if the integrated screws are implanted.

The Reliance Lumbar IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.

The Reliance Lumbar IBF System is comprised of lumbar intervertebral body fusion devices and associated surgical instruments. This submission adds a line extension, the Reliance Lumbar IBF-S devices, which consist of spacers made of PEEK Optima LT1 with Tantalum markers, and integrated screws, faceplates, and locking plates manufactured from titanium alloy.

The provided text describes a medical device, the Reliance Lumbar IBF System, and its regulatory clearance process (510(k)). It does not include details about acceptance criteria, device performance metrics, or any clinical studies involving human readers or AI algorithms. The "Performance Data and Substantial Equivalence" section only mentions mechanical testing performed on the device to establish substantial equivalence to predicate devices, focusing on physical properties rather than diagnostic performance.

Therefore, I cannot extract the requested information from the provided text as it is not present. The document focuses on regulatory approval based on substantial equivalence to existing medical devices, not on the diagnostic performance or AI-assisted interpretation of medical images.

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The Leva® Anterior Interbody System is a stand-alone system indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Leva® Anterior Interbody System is intended to be filled with autogenous bone graft material and used with the bone screws provided. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The Leva® Anterior Interbody System is family of stand-alone lumbar intervertebral body fusion devices fabricated from Ti-6A1-4V per ASTM F1472 and Ti-6A1-4V ELI per ASTM F136. The device includes integrated plate/screw fixation available in two configurations. In both device configurations, the surgeon inserts the bone screws through the anterior plate screw holes to provide fixation to the vertebral bodies. The device is intended to be filled with autogenous bone graft material. Both implant configurations are provided in various dimensions to accommodate the anatomical needs for a range of patients. The implants have convex endplates to conform to the bony endplates of the patient and ridges on the endplates to resist expulsion.

The provided text describes a medical device, the Leva® Anterior Interbody System, and its clearance process with the FDA. However, it does not contain information regarding acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML model.

The text is a 510(k) premarket notification for a traditional medical device (an intervertebral body fusion device) and focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing and material composition.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information) because the provided document is not about an AI/ML device or its performance evaluation.

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